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Crohn's DiseaseLEANCT03017014

A Study to Assess Safety and Effectiveness of Adalimumab for Treating Children and Adolescents With Crohn's Disease in Real Life Conditions

An observational study of Crohn's Disease, run by AbbVie at 24 sites in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The primary objective of this study is to evaluate long-term effectiveness of adalimumab in pediatric participants starting a treatment for Crohn's disease in real life conditions, namely to describe the time to loss of clinical benefit in a time to event approach. Read more about this study

Who is it for?
Ages 6 to 17 years
Conditions the study is for
Crohn's Disease
How many people
62 participants
Where
24 sitesFrance
Study dates
26 Sep 2017to 14 Oct 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Study population: Participants are children and adolescents with Crohn's disease

Who may be able to join

  • With confirmed diagnosis of Crohn's disease
  • Adalimumab-naïve patient (a patient having received an anti-TNF other than adalimumab may enter the study)
  • Starting a treatment with adalimumab
  • Guardian capable of and willing to grant authorization for use/disclosure of data collected and patient able to comply with the requirements of the study protocol.

Who cannot join

  • Participants with a history of treatment with adalimumab
  • Participants enrolled in a concomitant interventional clinical trial.

Trial locations and contacts

24 sites in 1 country.

24 sites in 1 country

France24 sites

  • CHU Batiment Robert Debre /ID# 152665

    Angers, 49933

  • CHU de Besancon - Jean Minjoz /ID# 154197

    Besançon, Doubs, 25000

  • CHU Bordeaux-Hopital Pellegrin /ID# 154620

    Bordeaux, 33076

  • Chu de Bordeaux Hopital /Id# 157926

    Bordeaux, 33076

  • Centre Hospitalier Universitai /ID# 155465

    Caen, 14033

  • CHU Hopital d'Estaing /ID# 152664

    Clermont-Ferrand, 63100

  • Hopital Jeanne de Flandre /Id# 155464

    Lille, 59037

  • Hopital de la Timone /ID# 160133

    Marseille, 13385

  • Hopital Jacques Monod /ID# 152663

    Montivillier, 76290

  • Hopital de la Source /ID# 159947

    Orléans, 45067

  • Hopital de la Source /ID# 165534

    Orléans, 45067

  • Robert Debre Hopital, FR /ID# 152666

    Paris, 75019

  • Hopital Armand Trousseau /Id# 152669

    Paris, 75571

  • Hopital Armand Trousseau /Id# 157092

    Paris, 75571

  • Necker Hopital, FR /ID# 152830

    Paris, 75743

  • Centre Hospitalier Lyon Sud /ID# 152667

    Pierre-Bénite, Auvergne-Rhône-Alpes, 69495

  • Centre Hospitalier Lyon Sud /ID# 152668

    Pierre-Bénite, Auvergne-Rhône-Alpes, 69495

  • Chu Lyon Sud /Id# 152838

    Pierre-Bénite, 69495

  • CHU de Rennes - Hospital Sud /ID# 152730

    Rennes, 35203

  • Charles Nicolle Hosp chu rouen /ID# 152670

    Rouen, 76031

  • Charles Nicolle Hosp chu rouen /ID# 158688

    Rouen, 76031

  • CHU Toulouse /ID# 153251

    Toulouse, Occitanie, 31025

  • Hopital Clocheville /ID# 152831

    Tours, Centre-Val de Loire, 37044

  • Hopitaux de Brabois Adultes /ID# 152729

    Vandœuvre-lès-Nancy, Lorraine, 54500

Other trials in France

About this study

Official title: Assessing Long-term Safety and Effectiveness of Adalimumab for Treating Children and Adolescents With Crohn's Disease in Real Life Conditions-LEA

The primary objective of this study is to evaluate long-term effectiveness of adalimumab in pediatric participants starting a treatment for Crohn's disease in real life conditions, namely to describe the time to loss of clinical benefit in a time to event approach. Main secondary objectives are to describe growth and pubertal development and to describe long-term safety. The participants will be followed-up up to 10 years.

Conditions
Crohn's Disease
Keywords
Crohn's Disease, Adalimumab, Humira®
Medical subject headings
Crohn Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03017014
Study groupRoleWhat they receive
Pediatric participants receiving adalimumabPediatric participants receiving adalimumab for CD in real-life conditions.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to loss of clinical benefit

    Loss of clinical benefit will be defined as one of the following:

    • Loss of efficacy leading to adalimumab discontinuation or
    • Introduction / reinforcement of other immunosuppressants (ratio dose/weight) or
    • Introduction / reinforcement of corticosteroids (ratio dose/weight; reinforcement of corticosteroids are allowed within the 4 first months after start of adalimumab)
    • Introduction of enteral nutrition
    • CD-related surgery, discontinuation of adalimumab due to adverse event, death.

    Measured: Up to 12 years

Secondary outcomes (22)

  1. Proportion of participants with dose escalation (dose and/or frequency of injections)

    Dosing and/or frequency of injections is monitored to assess dose escalation.

    Measured: Up to 12 years

  2. Median percent change from baseline in C-reactive protein (CRP)

    The median percent change from baseline in CRP is assessed at each time point.

    Measured: From Month 0 to 12 years

  3. Median percent change from baseline in calprotectin

    The median percent change from baseline in calprotectin us assessed at each time point.

    Measured: From Month 0 to 12 years

  4. Change from baseline in weighted Pediatric Crohn's Disease Activity Index (PCDAI)

    The Pediatric Activity Index (PCDAI) has become the standard outcome measure in pediatric Crohn's disease (CD) clinical research. The Weighted Pediatric Crohn's Disease Activity Index (wPCDAI) was developed to add weight to the items in the PCDAI and make it more feasible. In the wPCDAI, growth velocity, abdominal examination, and hematocrit are removed. The wPCDAI score can range from 0-125, with higher signifying severe disease activity.

    Measured: From Month 0 to 12 years

  5. Change in wPCDAI >= 37.5

    A change in wPCDAI >= 37.5 indicates improvement.

    Measured: From Month 0 to 12 years

  6. Incidence rate of CD-related hospitalizations

    Hospitalization will be determined from the health care utilization information.

    Measured: Up to 12 years

  7. Rate of clinical remission

    Clinical remission is weighted PCDAI < 12.5 or Harvey-Bradshaw index (HBI) <5. Rate of clinical remission will be described at each time point

    Measured: Up to 12 years

  8. Proportion of participants achieving mucosal healing at each time point

    Mucosal healing is assessed using SES-CD score (0 or 1).

    Measured: Up to 12 years

  9. Proportion of participants with steroid-free clinical remission at each time point

    The proportion of participants with steroid-free clinical remission is assessed at each time point.

    Measured: Up to 12 years

  10. Change in weight z-score

    Growth is assessed by monitoring changes in weight z-score.

    Measured: From Month 0 to 12 years

  11. Median percent change from baseline in high sensitivity C-reactive protein (hs-CRP)

    The median percent change from baseline in hs-CRP is assessed at each time point.

    Measured: From Month 0 to 12 years

  12. Assessing Mucosal healing

    Mucosal healing is assessed using Simple Endoscopic Score for Cronh's Disease (SES-CD) score (0 or 1).

    Measured: Up to 12 years

  13. Rate of steroid-free remission

    Steroid-free remission is defined as weighted PCDAI < 12.5 or HBI <5 and no daily intake of prednisone (whatever the route). Rate of steroid-free remission will be described at each time point.

    Measured: Up to 12 years

  14. Proportion of participants with fistula remission (in participants with fistulizing CD at entry)

    Fistula remission is defined as closure for at least 2 consecutive visits of all fistulae that were draining at baseline

    Measured: Up to 12 years

  15. Change in Tanner's staging

    Tanner's staging is used to assess growth and pubertal development.

    Measured: From Month 0 to 12 years

  16. Proportion of participants with immunomodulator-free clinical remission at each time point

    The proportion of participants with immunomodulator-free clinical remission is assessed at each time point.

    Measured: Up to 12 years

  17. Incidence rate of infectious events

    The incidence rate of serious and non-serious opportunistic infections is assessed.

    Measured: Up to 12 years

  18. Incidence rate of all-cause hospitalizations

    Hospitalization will be determined from the health care utilization information.

    Measured: Up to 12 years

  19. Proportion of participants with steroid tapering at each time point (steroids daily dosing lower than at baseline)

    The proportion of participants with steroid tapering i.e., steroids daily dosing lower than at baseline (week 0) is assessed.

    Measured: Up to 12 years

  20. Change in height z-score

    Growth is assessed by monitoring changes in height z-score

    Measured: From Month 0 to 12 years

  21. Proportion of participants with CD-related surgery

    CD-related surgery includes subtotal colectomy with ileorectostomy, colectomy with ileo-anal pouch, Koch pouch, ileostomy, small bowel resection, and etc.

    Measured: Up to 12 years

  22. Incidence rate of CD- or drug-related hospitalizations

    Hospitalization will be determined from the health care utilization information.

    Measured: Up to 12 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jan 2017 (estimated)
  2. Study start26 Sep 2017
  3. Primary completion14 Oct 2019
  4. Study completion14 Oct 2019

Why it stopped: Low enrollment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03017014
Sponsor's protocol ID
P15-759
Acronym
LEA
Status last verified
Oct 2020
First submitted
9 Jan 2017
Last updated
8 Oct 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Crohn's Disease, run by AbbVie at 24 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Low enrollment). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to loss of clinical benefit (time frame: Up to 12 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03017014.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2020.

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